The Ministry of Health is the competent authority for medical and in-vitro diagnostic devices in Guatemala. To register a medical or IVD device with the Health Authority the manufacturer must appoint a local company to submit the registrations.

Our country specific (*) regulatory services in Guatemala include:

Medical Device specific regulation strategy reports in Guatemala, Medical Device Registration with MOH, Guatemalan Representative and certification holder for Medical Device manufacturers, Guatemalan MOH Technical documents Preparation and Arazy Group unique line of GlobaR - Global Regulatory Hub™ products.

GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™

Please fill the following form and submit your inquiry or discuss it with one of our online specialists. Let's get your products registered in Guatemala!

(*) Guatemalan Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat services.